ENTYVIO Sales Surge Globally, Driven by Growing IBD Prevalence and Physician Demand for Targeted Therapies

DelveInsight's "ENTYVIO Market Size, Forecast, and Market Insight Report" offers in-depth analysis of ENTYVIO sales, positioning, and market outlook across major geographies. Developed by Takeda Pharmaceutical, ENTYVIO (vedolizumab) is a gut-selective monoclonal antibody approved for moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). The report provides insights into the product's mechanism of action, regulatory status, clinical development, and detailed historical and projected ENTYVIO sales from 2019 to 2032 across the 7MM [United States, EU4 (Germany, France, Italy, Spain), United Kingdom, and Japan].

Takeda's ENTYVIO (Vedolizumab) Overview
ENTYVIO is the first gut-selective biologic targeting α4β7 integrin, working by blocking lymphocyte trafficking into gastrointestinal tissues. Its selective mechanism reduces systemic immunosuppression risks, making it a valuable option in patients who failed or were intolerant to TNF inhibitors.

ENTYVIO sales have seen steady growth due to increased biologic uptake, earlier-line use, and the launch of subcutaneous (SC) formulations in key markets. In 2024, global ENTYVIO sales surpassed $6 billion, solidifying its position as a top-selling IBD therapy.

Takeda continues to expand ENTYVIO sales through real-world evidence, lifecycle management strategies, and ongoing clinical trials in new populations and indications. The brand's robust performance reflects growing physician confidence and its differentiation from systemic immunosuppressants.
With the inflammatory bowel disease landscape evolving and demand rising for safer, gut-targeted treatments, ENTYVIO sales are expected to maintain upward momentum through the next decade.
Dosage and administration

For Ulcerative Colitis (UC):
The recommended dosage is 300 mg administered by intravenous (IV) infusion at Weeks 0, 2, and 6, followed by every 8 weeks thereafter. Discontinuation is recommended in patients who do not exhibit therapeutic benefit by Week 14.

For Crohn's Disease (CD):
The recommended dosage is also 300 mg by intravenous infusion at Weeks 0, 2, and 6, then every 8 weeks thereafter. Similar to UC, therapy should be discontinued in Crohn's disease patients who show no evidence of benefit by Week 14.

Drug Details:
Drug Name: ENTYVIO (vedolizumab)
Molecule Type: Monoclonal antibody
Developer: Takeda Pharmaceuticals
Approvals: Ulcerative colitis and Crohn's disease (moderate to severe, adult patients)
Mechanism of Action: α4β7 integrin antagonist (inhibits lymphocyte trafficking to the gut)
Route of Administration: Intravenous (IV) and subcutaneous (SC)

Learn more about ENTYVIO's projected market size for ulcerative colitis and Crohn's disease @ https://www.delveinsight.com/report-store/entyvio-market-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ulcerative Colitis (UC) is a chronic inflammatory bowel disease marked by inflammation of the colon, leading to significant symptoms and long-term complications. In 2023, the diagnosed prevalent UC cases across the 7MM (US, EU4, UK, Japan) reached approximately 3.1 million, with the US accounting for ~47%, followed by Germany and Japan at ~10% each. This number is projected to grow steadily through 2034.

UC treatment remains complex, involving a range of options-from aminosalicylates and corticosteroids to advanced biologics and small molecules. Key therapies include anti-TNF agents (e.g., HUMIRA, REMICADE), anti-integrin vedolizumab (ENTYVIO), JAK inhibitors (XELJANZ), anti-IL12/23 (STELARA), and S1P modulators (ZEPOSIA). In March 2025, Celltrion launched STEQEYMA®, a biosimilar to STELARA, following FDA approval in late 2024.

The Ulcerative Colitis market size in the 7MM was valued at USD 8.4 billion in 2023 and is expected to grow significantly due to increased diagnosis, awareness, and the launch of new therapies. By 2034, vedolizumab is forecasted to generate the highest revenue in the U.S., followed by adalimumab, reflecting the strong uptake of targeted biologics.

Discover more about the ulcerative colitis market in detail @ https://www.delveinsight.com/report-store/ulcerative-colitis-uc-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Crohn's disease is a chronic, progressive inflammatory bowel disease (IBD) that causes deep tissue inflammation, primarily affecting the terminal ileum and colon. It often leads to complications such as strictures, fistulas, and ulcers. In 2024, the diagnosed prevalent cases in the US reached ~1.1 million, accounting for ~54% of the 7MM total, with EU4+UK and Japan comprising ~42% and ~4%, respectively.

Current treatment strategies focus on biologics such as adalimumab (HUMIRA and biosimilars), infliximab (REMICADE and biosimilars), STELARA (ustekinumab), along with systemic corticosteroids, immunosuppressants, and 5-ASAs. Adalimumab led the market in 2024 with ~USD 4 billion in revenue across the 7MM.

The Crohn's disease market size in the 7MM was valued at USD 10.8 billion in 2024 and is projected to grow at a CAGR of 4.3% through 2034. Market expansion will be fueled by increased disease awareness, improved diagnostics, and the anticipated launch of emerging therapies such as OMVOH and TREMFYA, expected to reshape the treatment landscape.

Dive deep into an in-depth assessment of the https://www.delveinsight.com/report-store/crohns-disease-cd-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Emerging Competitors of ENTYVIO
The Crohn's disease pipeline is robust with key companies such as RHB-104: RedHill Biopharma, VELSIPITY (Etrasimod): Arena Pharmaceuticals, Tulisokibart (MK-7240, PRA023): Merck, Duvakitug (TEV-574): Teva Pharmaceutical/Sanofi, LITFULO (Ritlecitinib/PF-06651600): Pfizer, AGMB-129: Agomab Therapeutics, and others involved in developing drugs.

Some of the drugs in the multiple myeloma pipeline include Etrasimod (APD334): Arena Pharmaceuticals/Pfizer, ABX464 (Obefazimod): Abivax, SHR0302 (Ivarmacitinib): Reistone Biopharma, Cobitolimod: InDex Pharmaceuticals, TREMFYA (Guselkumab): Janssen Pharmaceuticals, BT-11 (Omilancor): Landos Biopharma/NImmune, PRA023: Merck, Remestemcel-L: Mesoblast, PF-06651600 (ritlecitinib) and PF-06700841 (brepocitinib): Pfizer, and others.

To know more about the number of competing drugs in development, visit @ https://www.delveinsight.com/sample-request/entyvio-market-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Milestones of ENTYVIO
• May 2014: The FDA and European Commission (EC) granted simultaneous approval of ENTYVIO (IV) for treating adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) who have failed conventional or anti-TNF therapies.
• June 2014: ENTYVIO became commercially available in the United States for the treatment of UC and CD.
• November 2018: Takeda launched ENTYVIO in Japan for patients with moderately to severely active ulcerative colitis.
• May 2019: Japan's Ministry of Health, Labour and Welfare (MHLW) approved ENTYVIO for an expanded indication to treat moderately to severely active Crohn's disease.
• May 2020: The European Commission approved the subcutaneous (SC) formulation of ENTYVIO for maintenance treatment in adults with moderately to severely active UC or CD.
• March 2023: Japan's MHLW approved ENTYVIO Pens and prefilled syringes (108 mg SC) for maintenance therapy in ulcerative colitis.
• April 2023: The FDA accepted for review the resubmitted Biologics License Application (BLA) for the SC formulation of ENTYVIO as maintenance therapy in adults with moderately to severely active UC, following IV induction.
• September 2023: The FDA approved the SC formulation of ENTYVIO as maintenance therapy for UC, following IV induction.
• September 2023: The FDA accepted the BLA for SC ENTYVIO for maintenance treatment in Crohn's disease, post-IV induction.
• April 2024: The FDA approved the SC formulation of ENTYVIO for maintenance treatment in adults with moderately to severely active Crohn's disease, after prior induction with IV ENTYVIO.

ENTYVIO Market Dynamics
ENTYVIO (vedolizumab), a gut-selective biologic targeting the alpha 4 beta 7 integrin, stands out from traditional immunosuppressive therapies for ulcerative colitis (UC) and Crohn's disease (CD) due to its targeted mechanism of action and favorable safety profile. It is especially beneficial for patients unresponsive to anti-TNF therapies.

Key market drivers include the rising global prevalence of inflammatory bowel diseases (IBD), increasing demand for targeted biologics, and regulatory approvals across regions for both IV and SC formulations. ENTYVIO's expansion into new indications and emerging markets further supports its growth trajectory.

However, challenges remain. ENTYVIO competes with established biologics like Humira, Remicade, Stelara, and newer agents such as Xeljanz, alongside the rising threat of biosimilars. Its IV administration may reduce patient convenience compared to oral therapies, and pricing and reimbursement issues, particularly in cost-sensitive markets, could affect uptake. Although generally well-tolerated, adverse effects like infusion reactions and fatigue may impact adherence.

Opportunities lie in growing IBD awareness, improved diagnosis, and ongoing trials exploring new indications beyond UC and CD. Continued global expansion and strong clinical data will be key to ENTYVIO's sustained success.

Moving forward, differentiation through safety, targeted action, and effectiveness in hard-to-treat patients, coupled with strategic partnerships and patient support initiatives, will be vital to maintain its competitive position in the evolving IBD market.

Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ https://www.delveinsight.com/report-store/entyvio-market-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Report Introduction
2. ENTYVIO Overview
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5. ENTYVIO Market Assessment
6. SWOT Analysis
7. Analysts' Views
8. Appendix
9. DelveInsight Capabilities
10. Disclaimer
11. About DelveInsight
12. Report Purchase Options

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This release was published on openPR.